WO2025220049A1

WO2025220049A1 - Machine for preparing pre-dosed drug administration units

Info

Publication number: WO2025220049A1
Application number: PCT/IT2025/050085
Authority: WO
Inventors: Lorenzo Campanini
Original assignee: Logibiotech Srl
Current assignee: Logibiotech Srl
Priority date: 2024-04-15
Filing date: 2025-04-09
Publication date: 2025-10-23
Anticipated expiration: 2026-10-15

Abstract

The invention is directed to the field of machinery for the automated dosing of drugs for therapeutic plans intended for patients, and relates to a machine (1) for the preparation of pre-dosed drug administration units, in particular of the type in the form of tablets, lozenges, capsules or the like, comprising: - means for feeding blisters (BL) of the type provided with cells (A); - a three-dimensional scanner (2), adapted to detect the shape and arrangement of the cells (A) of one of said blisters (BL); - handling means adapted to move said blisters (BL) from said feeding means towards said three-dimensional scanner; - a shear (3) adapted to separate said cell (A1) from said blister (BL) on the basis of the coordinates (X, Y) detected by said three¬ dimensional scanner (2); - a packaging unit (4), adapted to receive the cells (A) separated by said shear (3); - an electrical panel (5) and a control panel (6); a robotic arm (7) to which said shear (3) is associated, so that said shear (3) is moved towards said blister (BL) to carry out the separation, by cutting, of a single cell (A1) when the blister (BL) is positioned below said three-dimensional scanner; - said shear (3) includes a tray (8) adapted to at least partially support said blister (BL) during the cutting step and to accommodate the cell (A1) separated from said blister (BL), supporting it until it reaches the unit packaging machine (4) where it will be abandoned.

Description

MACHINE FOR PREPARING PRE-DOSED DRUG ADMINISTRATION UNITS

Technical field of application

The invention relates to the field of machinery for the automated dosing of drugs according to treatment plans intended for patients in hospital or at home.

More specifically, the invention relates to a machine for the preparation of pre-dosed drug administration units, in particular of the type in the form of tablets, lozenges, capsules or the like.

Prior art

Poor adherence to physician prescriptions is the main cause of ineffectiveness of drug therapies and is associated with an increase in health care interventions, morbidity and mortality, representing a damage for patients, the health system and society.

Adherence to therapy means the patient's compliance with the doctor's recommendations regarding timing, doses and frequency of drug intake for the entire course of therapy.

Greater adherence in fact means a lower risk of hospitalization, fewer complications associated with the disease, greater safety and efficacy of treatments and a reduction in therapy costs.

There are several strategies to improve the safe and effective use of drugs, and first and foremost adherence to prescriptions: to date, simplified dosing regimens appear promising, with correct preparation of drugs that are part of patients’ therapeutic plans in single divided doses, and the direct involvement of pharmacists in drug management.

A process that unpacks and repackages drugs by placing them in small, transparent individual packages with the patient's name and time of intake, if performed manually, presents numerous critical elements: it is laborious and repetitive in all its steps, with a high risk of error; it requires the training of qualified professionals, with high costs; if the drugs must be removed from their packaging, problems arise regarding the impairment of the drugs themselves and their durability.

In order to try to overcome these problems, solutions have been developed that rely on special machinery to carry out more or less extensive parts of the process of obtaining the aforementioned single divided doses of drugs.

These solutions are essentially of a hospital type.

In the hospital sector, in fact, machines are already known for packaging pre-dosed drug administration units of the type comprising:

- means for feeding blisters of the type provided with cells, each containing a dose of drug;

- a scanning station comprising a three-dimensional scanner adapted to detect the shape and arrangement of the cells of one of said blisters and obtain the coordinates of cells available to be cut;

- a cutting station comprising a shear adapted to separate said blister into individual cells based on the coordinates detected by said three- dimensional scanner; - a packaging machine, adapted to receive the cells separated by said shear to determine the individual packaging thereof inside sealed sachets;

- a gripper adapted to pick up a blister from said feeding means and move it first towards said three-dimensional scanner, and subsequently from said three-dimensional scanner to said cutting station, supporting it during the shearing action.

In said machines, the gripper holds the blisters during the various movements by means of air suction cups; the packaging machine is placed below the cutting station, so that the individual separated cells fall inside.

Once the various sealed sachets, each containing a cell of drug, have been stored, it will be the task of an operator, or of an additional external machine, to group the individual sachets into doses intended for a patient's therapeutic plan.

Disadvantageously, these solutions show difficulties in application and implementation gaps that make them impossible to be adopted by community pharmacies, which due to their institutional role, qualifications and skills, as well as their widespread presence in the territories, are the outposts of reference for taking charge of the therapies of home-based patients, both chronic and non-chronic.

The most critical aspects are:

- the excessively large dimensions which currently do not allow for easy installation in limited spaces (current legislation does not in fact allow the machines to be positioned outside the perimeter of the pharmacy, the designated place for qualifications and authorisations for the handling of drugs);

- the complexity of managing the various movements made by the blisters, when moving from one workstation to another, with the risk of tampering with the blisters or losing the cutting references identified by the three-dimensional scanner;

- the failure to automate some operations, such as the grouping of individual sachets containing different drugs to complete the therapeutic plan of a single patient;

- the high construction costs.

Disclosure of the invention

The object of the invention is to overcome the drawbacks illustrated above by means of a machine for the preparation of predosed drug administration units which, due to its size, ease of use and purchase and management costs, may be adopted by community pharmacies, small hospitals, nursing homes and rest homes.

The objects of the invention are achieved with a machine for the preparation of pre-dosed drug administration units according to the independent main claim 1.

Further features of the invention are described in the dependent claims.

A machine for the preparation of pre-dosed drug administration units, according to the invention, produces the following important advantages: using a three-dimensional scanner, it allows the different types of blisters on the market as well as the shape, size and arrangement of the drug containment cells arranged thereon to be recognized, even if the blisters are incomplete; by positioning a shear at one end of a robotic arm, it is possible to cut the blister while it is still under the three-dimensional scanner, without having to move it with the risk of damaging the blister and losing the cutting coordinates; the orientable shear, by virtue of the articulation points of the robotic arm, allows precise cuts to be made while preserving the integrity of the individual cut blisters and those remaining on the blisters themselves, therefore without the risk of deblistering and without exposing the drug to contact with the external environment; through a careful arrangement of the constituent components, it has dimensions that allow for easy installation within limited spaces, such as pharmacy premises; through a high degree of automation of the constituent components, it is able to automatically carry out all the repetitive steps of drug selection, reduction into single doses, distribution and packaging of the drugs, as well as obtaining the desired results of efficiency, efficacy and safety of such steps.

In general, a machine according to the invention simplifies patient adherence to therapies, avoiding administration errors, by preparing drugs in single-dose units also composed of multiple drugs of different nature to be taken simultaneously at certain times of the day, organized according to pre-established intake plans. Brief description of the drawings

Further features and advantages of the invention will become apparent from the more detailed description set forth below, with the aid of the drawings which show a preferred embodiment thereof, illustrated by way of non-limiting example, in which:

- Figs. 1 and 2 show in axonometric view and in front plan view, respectively, the operating configuration of a machine for the preparation of pre-dosed drug administration units, according to the invention;

- Figs. 3-6 show, in axonometric view, some of the components of the machine.

Detailed description of the invention

With reference to Figures 1 and 2, a machine 1 for packaging predosed drug administration units, according to the invention, is illustrated.

Said machine 1 comprises:

- a ground support frame 20 comprising a work surface 21 and opening doors 22’ and 22” for access to the work surface 21 and to a compartment underneath it of the machine itself, respectively;

- means for feeding blisters BL of the type provided with cells A each containing a dose of drug;

- a three-dimensional scanner 2, adapted to detect the shape and arrangement of the cells A of one of said blisters BL and obtain the coordinates X, Y of a cell A1 available to be cut;

- handling means adapted to move said blisters BL towards said three-dimensional scanner 2, managing one blister at a time;

- a shear 3 adapted to separate said cell A1 from said blister BL on the basis of the coordinates X, Y detected by said three-dimensional scanner 2;

- a packaging unit 4, adapted to receive the cells A separated by said shear 3 to cause the packaging thereof inside sealed sachets also including cells A coming from blisters BL of drugs of different nature, optionally then grouped in reels defining entire therapeutic plans of individual patients divided into single doses of administration;

- a robotic arm 7 to which said shear 3 is associated, so that said shear 3 is not fixed as in traditional machines, but is movable to be moved towards said blister BL so as to carry out the separation, by cutting, of a single cell A1 at a time when the blister BL is positioned in a stable manner.

For this purpose, said shear 3 comprises a tray 8 adapted to at least partially support said blister BL during the cutting step (see then Fig. 5).

Furthermore, said tray 8 has the function of collecting the single cell A separated from the blister BL, supporting it until it reaches the packaging unit 4 where it will be abandoned.

Finally, said machine 1 comprises:

- an electrical panel 5, adapted to cause the coordinated operation of the components of the machine 1 ;

- a control panel 6, adapted to allow the insertion of the therapeutic plan, the control and management of the components of the machine 1 by an operator.

Again with reference to Figures 1 and 2, said feeding means comprise:

- a dynamic warehouse 23 provided with overlapping shelves 24, each of which is adapted to contain a single blister BL of drugs;

- vertical movement means 25 for said shelves 24 adapted to bring the single blister BL to be processed to a height compatible with said three-dimensional scanner 2.

Said vertical movement means 25 comprise a latch.

Said horizontal movement means instead, adapted to move said blisters BL from said dynamic warehouse 23, or from one of said shelves 24, towards said three-dimensional scanner 2, comprise an index with horizontal movement of the back and forth type (not illustrated).

Furthermore, said machine 1 comprises a static storage warehouse 26, containing the empty blister BL boxes present on the shelves 24 of the dynamic warehouse 23.

The three-dimensional scanner 2 is of a known type and comprises a plurality of lasers that project two opposing lines onto the blister BL. These lines may be of three different colours (red, blue or green) activated depending on the colour of the blister BL to be scanned. A linear axis moves the laser along the entire length of the blister BL, while a camera films the profile created by the raised cells. A software algorithm then converts the profile footage into a three- dimensional reconstruction of the blister BL. The three-dimensional scanner 2 advantageously allows the recognition of the different types of blisters BL present on the market, and the detection of the shape, size and arrangement of the cells A, even if the blisters are incomplete.

The packaging unit 4 is of the vertical type, sized to fit well into the overall dimensions of the machine 1 , and is provided in the compartment located underneath the work surface 21 of the machine 1 closed by the door 22”.

With particular reference to Figure 3, a robotic arm 7 according to the invention is illustrated.

The robotic arm 7 is of the SCARA (Selective Compliance Assembly Robot Arm) type and comprises articulation points R1 , P2, P3, P4, of which the first P1 is adapted to allow bidirectional translation thereof, together with the shear 3, along a vertical axis, and the remaining P2, P3, P4 are adapted to allow bidirectional rotation thereof, always together with the shear 3, on the same number of vertical axes, parallel to a horizontal work surface 21 of the machine 1.

Said robotic arm 7 extends from said work surface 21 of machine 1.

With particular reference to Figures 4 and 5, said shear 3 is illustrated in detail.

The shear 3 provided on the robotic arm 7 comprises:

- a lower half-shear 9 including said tray 8;

- an upper half-shear 10, provided on adjacent orthogonal sides with a blade 11 shaped at a right angle, adapted to cause the separation of an available cell A1 from the single blister BL.

Said blade 11 is interchangeable, so it may be easily replaced in case of wear.

In particular, said blade 11 is sharpened like a scalpel and comprises an inclined cutting profile, provided with a tip 27, positioned at a right angle to the blade itself, the latter then being connected towards the two opposite ends.

Said lower half-shear 9 comprises linear seats 12, of the channel type, arranged along two adjacent orthogonal sides of said tray 8, and arranged orthogonally to each other to reproduce the right angle of said blade 11. Said linear seats 12 are in fact adapted to receive the cutting profile of said blade 11 of said upper half-shear 10 at the moment of maximum mutual approach of the half-shears themselves during the cutting step.

Said lower half-shear 9 includes an L-shaped profile 13 arranged spaced along two consecutive sides of said tray 8, so as to create said linear seats 12 between the tray 8 and the L-shaped profile 13.

Said shear 3 provided on the robotic arm 7 further comprises a support flange 14, adapted to allow the arrangement thereof at an articulation point P4 of the robotic arm 7 corresponding indicatively to the “wrist” of the robotic arm itself.

Said articulation point P4 of the robotic arm 7 allows a 180° rotation of said shear 3 around a vertical axis, to adapt the cutting angle of said blade 11 to the arrangement of the cells of the individual blisters placed on the tray of the lower half-shear.

Furthermore, said shear 3 includes movement means, adapted to regulate the vertical excursion of the upper half-shear 10 to adapt the positioning height of the blade 11 , before cutting, to the dimensions, detected by said three-dimensional scanner 2, of the cells A of the blisters BL placed on the tray 8 of the lower half-shear 9.

Said movement means include a linear screw guide 15 and an electric motor 16 dedicated to said linear guide, as well as a lead screw associated with said upper half-shear 10.

On board said shear 3 there is a photocell 28 adapted to act as a zero check for the initial position of the upper half-shear 10 with respect to the tray 8 of the lower half-shear 9 on which the blister BL rests at least partially.

As stated above, said packaging unit 4 is of the vertical type and is provided in the compartment located underneath the work surface 21 of said machine 1 .

With particular reference to what is illustrated in Figure 6, said work surface 21 comprises an access mouth 29 to said packaging unit 4, through which the cells A separated by said shear 3 are fed and temporarily supported by said tray 8 until they reach said access mouth 29.

A reference index 30 is provided at said access mouth 29, fixed on said work surface 21 . Said stop index 30 partially occupies the space located above said access mouth 29 and is adapted to cooperate with said shear 8, touching the tray 8, to facilitate the fall of the individual cells A from the same tray 8 inside said access mouth 29.

The operating steps of a machine 1 for the preparation of predosed drug administration units, according to the invention, are described below.

The pharmacy operator places the blisters BL of the drugs taken from his own warehouse, or from the boxes stored in said static warehouse 26, on the shelves 24 of the dynamic warehouse 23 of machine 1 .

Once the blisters BL have been loaded, based on the order of administration of the drugs reported on a patient's prescription, machine 1 sequentially proceeds to: align the shelf 24 on which the blister BL containing the first drug to be retrieved is placed to the level of said three-dimensional scanner 2; feed under said three-dimensional scanner 2 said blister BL by means of said back and forth type index; scan the blister BL using the three-dimensional scanner 2, recognising the shape and arrangement of the cells A and the X, Y coordinates of the first cell A1 available on said single blister BL; bring said shear 3 closer to said scanned blister BL by means of the movements of said robotic arm 7; orient the position of said shear 3 based on the shape and arrangement of the cells A and the X, Y coordinates of the first cell A1 available on said single blister BL, via said robotic arm 7 (Fig. 5); support a portion of said blister BL by means of the tray 8 of said lower half-shear 9; separate the first available cell A1 on said blister BL, through the cooperation between said blade 11 of said upper half-shear 10 and said linear seats 12 of said lower half-shear 10; bring said shear 3 closer to said packaging unit 4 by means of the movements of said robotic arm 7; introduce said first cell A1 separated from the blister BL into the access opening 29 of the packaging unit 4 through the cooperation of said shear 3 with said reference index 30 (Fig. 6) which, by virtue of the movement of tray 8, moves the cell A1 until it falls into mouth 29; reposition said blister BL on the respective shelf 24 of the dynamic warehouse 23 via said robotic arm 7; repeat the operations listed above for each blister BL of drugs reported on the patient's prescription.

The cells A1 of the blisters BL introduced into the packaging unit 4 are collected, individually and/or together, inside sealed sachets, obtained from continuous sheets of plastic materials, adapted to form reels, which may be rolled up or folded on themselves, which define an entire therapeutic plan prescribed to the patient by his or her own doctor.

Advantageously, the packaging unit 4 prints on each sachet the day and time designated for the patient to take the drugs contained therein.

Claims

1. Machine (1 ) for packaging pre-dosed drug administration units for a patient's treatment plan comprising:

- means for feeding blisters (BL) of the type provided with cells (A) each containing a dose of drug;

- a three-dimensional scanner (2), adapted to detect the shape and arrangement of the cells (A) of one of said blisters (BL) and obtain the coordinates (X, Y) of a cell (A1 ) available to be cut;

- handling means adapted to move said blisters (BL) from said feeding means towards said three-dimensional scanner, managing one blister (BL) at a time;

- a shear (3) adapted to separate said cell (A1 ) from said blister (BL) on the basis of the coordinates (X, Y) detected by said three- dimensional scanner (2);

- a packaging unit (4), adapted to receive the cells (A) separated by said shear (3) to cause the packaging thereof inside sealed sachets also including cells (A) coming from blisters (BL) of drugs of different nature;

- an electrical panel (5), adapted to cause the coordinated operation of the components of said machine (1 );

- a control panel (6), adapted to allow the insertion of a therapeutic plan, the control and management of the components of said machine (1 ) by an operator, characterized in that:

- said machine (1 ) includes a robotic arm (7) to which said shear (3) is associated, so that said shear (3) is moved towards said blister (BL) to carry out the separation, by cutting, of a single cell (A1 ) when the blister (BL) is positioned below said three- dimensional scanner (2);

- said shear (3) includes a tray (8) adapted to at least partially support said blister (BL) during the cutting step and to accommodate the cell (A1 ) separated from said blister (BL), supporting it until it reaches the unit packaging machine (4) where it will be abandoned.

2. Machine (1 ) according to claim 1 , characterized in that said robotic arm (7) includes articulation points (P1 , P2, P3, P4), of which the first (P1 ) is adapted to allow the translation of the robotic arm (7), and of the shear (3) associated with it, along a vertical axis, and the remaining ones (P2, P3, P4) are adapted to allow the rotation of the robotic arm (7) and the shear (3) around the same number of vertical axes.

3. Machine (1 ) according to claim 1 , characterized in that said shear (3) comprises:

- a lower half-shear (9) including said tray;

- an upper half-shear (10), provided with a blade (11 ) shaped at a right angle, adapted to cause the separation of an available cell (A1 ) from the single blister (BL).

4. Machine (1 ) according to claim 3, characterized in that said blade (11 ) includes a cutting profile provided with a tip (27), placed at its right angle and connected towards the opposite ends.

5. Machine (1 ) according to claim 3, characterized in that said lower half-shear (9) includes linear seats (12), adapted to receive the cutting profile of said blade (11 ) of said upper half-shear (10) at the moment of maximum mutual approach of the half-shears themselves.

6. Machine (1 ) according to claim 3, characterized in that said lower half-shear (9) includes an L-shaped profile (13) arranged spaced along two consecutive sides of said tray (8), so as to create said linear seats (12) between the tray (8 ) and the L-shaped profile (13).

7. Machine (1 ) according to claim 3, characterized in that said shear (3) comprises a support flange (14), adapted to allow its preparation at an articulation point (P4) of said robotic arm (7) corresponding approximately to a “wrist” of the robotic arm itself, where said articulation point (P4) of said robotic arm (7) allows the 180° rotation of said shear (3) around a vertical axis to adapt the cutting angle of said blade (11 ) to the arrangement of the cells (A) of the individual blisters (BL) resting on the tray (8) of said lower half-shear (9).

8. Machine (1 ) according to claim 3, characterized in that said shear (3) includes movement means, adapted to regulate the vertical excursion of said upper half-shear (10) to adapt, before cutting, the positioning height of said blade (11 ) to the dimensions, detected by said three-dimensional scanner (2), of the cells (A) of the blisters (BL) placed on the tray (8) of said lower half-shear (9).

9. Machine (1 ) according to claim 8, characterized in that said movement means include a linear screw guide (15), an electric motor (16) dedicated to said linear guide and a lead screw associated with said upper half-shear (10).

10. Machine (1 ) according to claim 1 , characterized in that said blister feeding means (BL) include:

- a dynamic warehouse (23) provided with overlapping shelves (24), each of which is adapted to contain a single blister (BL) of drugs;

- vertical movement means (25) for said shelves (24) comprising a latch;

- horizontal movement means, comprising an index with horizontal movement of the back and forth type, adapted to move said blisters (BL) from one of said shelves (24), towards said three- dimensional scanner (2).

11 . Machine (1 ) according to claim 1 , characterized in that:

- said packaging unit includes an access mouth (29) through which the cells (A) separated by said shear (3) and temporarily supported by said tray (8) are fed;

- said machine (1 ) includes a stop index (30), arranged to partially occupy the space located above said access mouth (29) and adapted to cooperate with said shear (3) to facilitate the fall of the individual cells (A) from the same tray (8) inside said access mouth (29).